Rituximab

Chemical formula: C6416H9874N1688O1987S44

Therapeutic indications

Rituximab is indicated for:

Monotherapy in stage III-IV follicular non-Hodgkin's lymphoma

Population group: only adults (18 years old or older)

Truxima monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemo-resistant or are in their second or subsequent relapse after chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

375 mg/m² body surface area once weekly for 4 weeks

Diffuse large B cell non-Hodgkin's lymphoma, CD20 positive

Population group: only infants (40 days - 1 year old) , children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)

Rituximab is indicated for the treatment of adult patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.

Rituximab in combination with chemotherapy is indicated for the treatment of paediatric patients (aged ≥6 months to <18 years old) with previously untreated advanced stage CD20 positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL)/Burkitt leukaemia (mature B-cell acute leukaemia) (BAL) or Burkitt-like lymphoma (BLL).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

375 mg/m² body surface area on day 1 of each chemotherapy cycle for 8 cycles

375 mg/m² BSA

Chronic lymphocytic leukaemia

Population group: only adults (18 years old or older)

Rituximab in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

375 mg/m² body surface area on day 0 of the first treatment cycle followed by 500 mg/m² body surface area on day 1 of each subsequent cycle for 6 cycles in total

Rheumatoid arthritis

Population group: only adults (18 years old or older)

Rituximab in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic medicinal product (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.

Rituximab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1,000 mg followed by a second 1.000 mg dose 2 weeks later

Granulomatosis with polyangiitis and microscopic polyangiitis

Population group: only adults (18 years old or older)

Rituximab, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).

Rituximab, in combination with glucocorticoids, is indicated for the induction of remission in paediatric patients (aged ≥2 to <18 years old) with severe, active GPA (Wegener’s) and MPA.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

375 mg/m² body surface area once weekly for 4 weeks and thereafter maintenance treatment no sooner than 16 weeks after the last rituximab infusion

375 mg/m² BSA once weekly for 4 weeks

Pemphigus vulgaris

Population group: only adults (18 years old or older)

Rituximab is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

For this indication, competent medicine agencies globally authorize below treatments (click for details):

1.000 mg followed two weeks later by a second 1.000 mg dose and thereafter 500 mg maintenance dose at months 12 and 18

Previously untreated follicular non-Hodgkin's lymphoma

Population group: only adults (18 years old or older)

Rituximab is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy.

Rituximab maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

375 mg/m² body surface area on day 1 of each chemotherapy cycle, for up to 8 cycles, and thereafter 375 mg/m² body surface area once every 2 months

Relapsed/refractory follicular non-Hodgkin's lymphoma

Population group: only adults (18 years old or older)

Rituximab maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy.

For this indication, competent medicine agencies globally authorize below treatments (click for details):

375 mg/m² body surface area on day 1 of each chemotherapy cycle, for up to 8 cycles, and thereafter 375 mg/m² body surface area once every 3 months

Contraindications

Rituximab is contraindicated in the following cases:

Active, severe infections

Infectious disease

Severely immunocompromised state

Immunodeficiency

Severe heart failure or severe, uncontrolled cardiac disease

at least one of

Heart failure New York Heart Assosiation Class IV
Heart disease

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